Variable flow control device, system and method

ABSTRACT

A device, system and method are provided for controlling the rate of infusion of fluids during infusion therapy using non-electric infusion devices. Rotation of a flow regulator dial causes an orifice connected to the inlet to modify its position relative to a particular one or more orifices or groove portions, the characteristics of which provide a certain flow rate characteristic. The flow regulator allows for the infusion pump to infuse at a rate that may be varied during use by the user. Additionally, the flow regulator is made from a material selected to operate under a wide range of pressures, from 5-40 PSI, making the flow regulator compatible with pressurized devices, such as, a non-electric pump.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/709,759, filed Sep. 20, 2017; which is a continuation of U.S. patentapplication Ser. No. 15/397,153, filed Jan. 3, 2017; which is acontinuation of U.S. patent application Ser. No. 13/690,702, filed Nov.30, 2012, which claims the benefit of U.S. Patent ProvisionalApplication No. 61/565,120, filed Nov. 30, 2011; incorporated herein byreference in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a device, system and method useful ininfusion therapy, and more particularly, useful for varying the flowrate during infusion therapy.

Description of the Related Art

Infusion therapy requires the use of an infusion device (a source ofpositive pressure). There are several types of infusion devices whichinclude: mechanical pumps, elastomeric pumps, gravity flow,electric/electronic pumps among others. Non-electric pumps and gravityinfusions have a general disadvantage in that they often do not providea sufficiently stable flow rate.

Flow rate control in mechanical, elastomeric and other non-electricalpumps is generally accomplished with the use of certain small diametertubing (rate set) that regulates the flow. This presents the followinglimitations:

The flow cannot be adjusted during the infusion. Instead a new infusionset has to be used when a different rate is required. This adds cost andit may increase the risk of contamination.

In order to change the flow rate, the tubing diameter has to change andthus multiple rate sets have to be made available and changed duringinfusion. This may or may not be possible during certain therapies.

The nominal flow rate of these sets does not correspond to the flow rateduring use due to the viscosity of the fluid often leading to patientand clinician confusion and errors.

Flow rate control in gravity infusions is generally accomplished withroller clamps or flow regulators that allow clinicians to determine acertain position to obtain a desired flow rate. Roller clamps areimprecise and they have generally no flow rate markings. Flow regulatorsin the prior art offer limited accuracy, versatility and pressure ratingperformance.

A clinician using flow regulators is generally unaware of the variousfactors that affect the performance of flow regulators including, theimprecise position of the flow regulator, relative temperature, relativehumidity, patient backpressure factors, and the variability of pressurefrom the source of the medication. These factors can result insignificant variances in flow rates and could adversely affect patientsto a significant extent.

Flow rate controllers are generally labeled in ml/hour without takinginto account the specific effect of the viscosity of the fluid which hasa significant effect on the flow rate thus invalidating the significanceof the markings of the device and confusing the clinician.

Safety concerns regarding infusions have been escalating in hospitalsand in regulatory circles. The FDA has started presenting new guidancedocuments that regulate infusion system submissions to increase thethreshold of requirements for such infusion systems.

Additional design requirements are becoming more apparent in Europe,Canada, Japan, the US and many other countries relative to improvedcontrol of flow rates and specific material biocompatibility regulationsfor fluid delivery devices.

Non-electric infusions systems are generally controlled by certain smalldiameter tubing (rate set) that regulates the flow. This method presentslimitations including inability to change flow rate without changing therate set, incorrect flow rate labeling due to the varying viscosities offluids administered, and undesired flow rates due to device designlimitations, patient and environmental factors. U.S. Pat. No. 4,904,239(“the '239 patent”) to Winchell et al., discloses an infusor having adistal flow regulator for dispensing a liquid under pressure at apredetermined flow rate. The '239 patent discloses the use of anon-adjustable, preselected flow regulator including a capillary bore.Col. 5 of the '239 patent, lines 9-14, disclose that a seal designpermits the use of dramatically different length regulators fordifferent desired flow rates, while still using the same size housingand connecting means, i. e, the preselected flow rate of the infusor canbe changed simply by changing the length of the flow regulator. Thus, aparticular flow regulator of the '239 patent has limited flow controlcharacteristics.

U.S. Pat. No. 5,009,251 (“the '251 patent”) to Pike et al., discloses avariable fluid flow controller for regulating the rate of flow from asource of fluid under pressure, including a plurality of unique flowrestriction passageways, a valve associated with each passageway and arotatable cam for selectively opening any one of the valves whilemaintaining the remaining valves closed. The flow restriction passagewayof the '251 patent preferably comprises a channel etched on the surfaceof a first silicon wafer and enclosed by a second wafer to form a fluidflow passageway, one of the first or second wafers having a plurality ofapertures therethrough for intersecting the passageway at variousdistances along its length.

U.S. Pat. No. 5,234,413 (“the '413 patent”) to Wonder et al., disclosesan infusion rate regulating device for varying the rate of flow offluids for infusion to a patient at extremely low, but constant, flowrates. The regulator of the '413 patent is interposed at a point on asupply tube between a fluid reservoir and a patient. An input portdirects fluid to a fluid metering groove of variable cross-sectionalarea on a metering plate which is formed as a part of the output port.The metering plate is rotated axially, relative to the input port,allowing fluid to enter the fluid metering groove at any point and flowtoward the output port through a fluid metering groove which increasesin depth or cross-sectional area at an essentially constant rate.Depending on the point at which the fluid enters the fluid meteringgroove flow path of the device in the '413 patent, the flow rateselected can be any rate from full off to full flow. Typicallyelastomeric devices operate in ranges under 5 psi.

What is needed is a flow control device for a gravity flow or mechanicalinfusion system that provides clinicians with precision in controllingthe flow rate through the device for ranges of pressure higher thanconventional elastomeric devices.

SUMMARY OF THE INVENTION

A device, system and method are provided for controlling the rate ofinfusion of fluids during infusion therapy using non-electric infusiondevices. The flow control device of the present invention improves flowcontrol, as well as safety resulting from such improved flow ratecontrol, when compared to the performance of flow regulator devices inthe prior art. The flow control device of the present invention has adesign and method of construction that optimizes flow rate andfunctionality, safety and ergonomics in applications such as those thatcan be used with non-electric pumps including, but not limited to:mechanical pumps, elastomeric pumps, and other similar devices orapplications.

An embodiment of the disclosure is a flow rate control device configuredfor connection in a flow path between a non-electric infusion pump and apatient, the flow rate control device comprising: an inlet handle; anoutlet handle; a fluid path disposed between said inlet handle and saidoutlet handle, said fluid path having manually adjustable dimensions;and said inlet handle and said outlet handle composed of materials thatcan withstand pressures of from 5 PSI-40 PSI. In an embodiment, the flowrate control device further comprises a plurality of differently sizedorifices for fluid flow therethrough located on at least one of saidinlet handle or said outlet handle. In an embodiment, the flow ratecontrol device further comprises a seal sealingly engaged between saidinlet handle and said outlet handle.

An embodiment of the disclosure is a variable flow rate infusion system,comprising: a non-electric infusion pump that dispenses fluidpressurized to between 5 PSI and 40 PSI; and a flow control deviceaccording to claim 1 in fluid communication with said non-electricinfusion pump. In an embodiment, said materials include at least one ofpolycarbonate and another material having a similar hardness coefficientto polycarbonate.

In one particular embodiment of the invention, a variable flow controldevice is provide in which the rotation of a flow regulator dial causesan orifice connected to the inlet to modify its relative position withrespect to a groove or open-topped channel connected to the fluidoutlet, via an orifice at one end of the groove, thus defining the fluidpath. In this embodiment, one or more characteristics (diameter, width,depth, etc.) of the groove may be varied along the length of the groove,as desired.

In another particular embodiment of the invention, rotation of aregulator dial causes an orifice connected to the inlet to align withone of a plurality of orifices connected to the outlet. The diameter ofeach orifice of the plurality may be graduated such that the differentorifices represent a percentage of flow from 1% to 100% in specificincrements. In one particular embodiment, ten orifices are provided eachorifice providing a 10% greater flow rate of the total possible flowrate than its immediately prior neighbor, starting from the smallestorifice to the largest, with the first orifice providing 10% of thetotal possible flow rate and the tenth orifice providing 100% of thetotal possible flow rate.

In a further particular embodiment of the invention, rotation of a flowregulator dial causes an orifice connected to the inlet to align withone of various combinations of orifices connected to the outlet thatrepresent the permutation of orifices as a digital counter (BINARY).

Additionally, in a further particular embodiment of the invention,improved flow regulation or control is achieved by combining two or moreadjustable dial layers, each having a variable flow control mechanism inaccordance with the present invention. In one particular embodiment, oneor more additional variable flow control layers are added after thefirst or main variable flow control layer to provide a combination ofcoarse and fine control levels, thus greatly enhancing the actual flowrate controllability through the device.

The present invention solves important limitations inherent tonon-electric infusion systems. Other features which are considered ascharacteristic for the invention are set forth in the drawings and theappended claim.

Although the invention is illustrated and described herein as embodiedin a variable flow control device, system and method, it is neverthelessnot intended to be limited to the details shown, since variousmodifications and structural changes may be made therein withoutdeparting from the spirit of the invention and within the scope andrange of equivalents of the claims.

The construction of the invention, however, together with additionalobjects and advantages thereof will be best understood from thefollowing description of the specific embodiment when read in connectionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be made to the following detailed description, taken inconnection with the accompanying drawings in which like referencenumerals refer to like elements and in which:

FIG. 1 is an exploded, perspective view of a flow control device inaccordance with one particular embodiment of the invention;

FIG. 2 is an exploded view, taken from the side, of the flow controldevice of FIG. 1;

FIG. 3 is a top plan view of a flow control device in accordance withone particular embodiment of the invention;

FIG. 3A is a cut-away view of the flow control device of FIG. 3, takenalong the section lines A-A;

FIG. 4A is a side plan view of a portion of a flow control device inaccordance with one particular embodiment of the invention;

FIG. 4B is a top plan view of the portion of the flow control device ofFIG. 4A;

FIG. 5A is a side plan view of a portion of a flow control device inaccordance with one particular embodiment of the invention;

FIG. 5B is a top plan view of the portion of the flow control device ofFIG. 5A;

FIG. 6A is a side plan view of a portion of a flow control device inaccordance with one particular embodiment of the invention;

FIG. 6B is a top plan view of the portion of the flow control device ofFIG. 6A;

FIG. 7 is an exploded, perspective view of a flow control device inaccordance with another particular embodiment of the invention;

FIG. 8 is an exploded view, taken from the side, of the flow controldevice of FIG. 7;

FIG. 9 is a top plan view of a flow control device in accordance withone particular embodiment of the invention;

FIG. 9A is a cut-away view of the flow control device of FIG. 9, takenalong the section lines A′-A′;

FIG. 10A is a side plan view of a portion of a flow control device inaccordance with one particular embodiment of the invention;

FIG. 10B is a top plan view of the portion of the flow control device ofFIG. 10A;

FIG. 11A is a side plan view of a portion of a flow control device inaccordance with one particular embodiment of the invention;

FIG. 11B is a top plan view of the portion of the flow control device ofFIG. 11A;

FIG. 12A is a side plan view of a portion of a flow control device inaccordance with one particular embodiment of the invention;

FIG. 12B is a top plan view of the portion of the flow control device ofFIG. 12A;

FIG. 13 is an exploded, perspective view of a flow control device inaccordance with a further particular embodiment of the invention;

FIG. 14 is an exploded view, taken from the side, of the flow controldevice of FIG. 13;

FIG. 15 is an exploded, perspective view of a flow control device inaccordance with still another particular embodiment of the invention;

FIG. 16 is an exploded view, taken from the side, of the flow controldevice of FIG. 15;

FIG. 17 is a top plan view of a flow control device in accordance withone particular embodiment of the invention;

FIG. 17A is a cut-away view of the flow control device of FIG. 17, takenalong the section lines A″-A″;

FIG. 18 is a top plan view of the portion of the flow control device inaccordance with one particular embodiment of the invention;

FIG. 19 is a perspective view of an infusion system with a pump, asyringe and a flow regulator in accordance with one particularembodiment of the present invention;

FIG. 20 is a perspective view of a flow regulator according to theinvention and its connectors to the remainder of the infusion system;

FIG. 21 is a perspective view of a flow control device in accordancewith still another particular embodiment of the present invention;

FIG. 22 is a perspective view of an infusion pump that can be used in aninfusion system in accordance with one particular embodiment of theinvention; and

FIG. 23 is a perspective view of an exemplary luer lock for use in oneparticular embodiment of an infusion system in accordance with thepresent invention.

FIG. 24 is an exploded, perspective view of a flow control device inaccordance with still another particular embodiment of the invention;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIGS. 1-6B, there is shown a variable flow controldevice 100 in accordance with one particular embodiment of the presentinvention. The flow control device 100 optimizes the delivery of fluidsin conjunction with non-electric infusion pumps and gravity flow, so asto control the infusion of fluids for infusion therapy administrationwithout the use of electronic infusion devices. The flow control device100 is a variable flow regulator that can be provided as part of acomplete infusion system or set. One example of one such completeinfusion system or set is illustrated in FIG. 19.

In the present preferred embodiment, the flow control device 100 of thepresent invention is constructed with biocompatible materials.Preferably, flow control device 100 is designed with a geometry that isconducive to hand manipulation with sufficient gripping areas to avoidslippage and to facilitate rotation as a way to select a specific flowrate. The flow control device 100 is made with materials that allow forthe infusion apparatus to be operated under gravity, as well as,pressurized at higher pressure ranges, such as from 5 PSI-40 PSI, asrequired by elastomeric and mechanical infusion devices designed todeliver fluids that require pressurized chambers in the 5-40 PSI range.The main flow rate variation is accomplished by adjusting the fluid pathdimensions. Rotation of one half of the flow regulator component in onedirection moves the fluid path exit point along the channel andeffectively changes total fluid path length and diameter such that fluidflow decreases or stops depending on the degree to which it is rotated.Rotation in the opposite direction moves the fluid path exit pointtowards the upstream fluid path entry point, changing effective internalfluid path length and diameter such that flow is increased.

The flow control device 100 includes three primary elements: an inlethandle 110; an outlet handle 130; and a seal 120, enclosed (i.e.,“sandwiched” or sealingly engaged) between the inlet handle 110 and theoutlet handle 130. The outer surface of the inlet handle 110 includes acircumferential face or viewing portion 112 upon which a scale 114showing selectable flow rates is imprinted. In the present embodiment,the inlet handle 110 and scale 114 provide a flow regulator dial that isrotatable relative to the outlet handle 130 to control the fluid flowthrough the device 100.

The inlet handle 110 includes a port 116 which serves as the fluid inletto the device 100. The port 116 includes a distal orifice 116 a thatallows fluid input to the port 116 to flow to the rest of the device100. The inlet handle 110 additionally includes a shaft 118 thatincludes a collar portion 118 a that engages a snap fitting 138 of theoutlet handle 130 to form a rotatable snap-fit coupling which holds theseal 120 in place between the inlet handle 110 and the outlet handle130. More particularly, the shaft 118 passes through a central hole 122in the seal 120 and is entrapped in the snap fitting 138 of the outlethandle 130, by its collar 118 a.

The outlet handle 130 includes an internal groove or “channel” 132 openat the top and of varying diameter, through which fluid passes to anorifice 132 a at one end of the groove 132 connected to an outlet port134. The relative positions (i.e., overlap) of the inlet handle orifice116 a and the outlet handle groove 132 determines the flow rate. Theoutlet port 134 of the outlet handle 130 permits fluid to flow from thedevice 100 to tubing connected to a connector, preferably some form ofuniversal connector, to allow connection to a patient.

During assembly, the seal 120 is seated into an area of similar geometryto the seal 120 in the order to maintain the hole or orifice 124 throughthe seal 120 in alignment with the inlet handle orifice 116 a. Forexample, as can be seen more particularly from FIGS. 5B and 6B, thelower portion of the inlet handle 110 includes a chamber or cavity 117,sized and shaped to receive the seal 120 without permitting slippage.For example, the projections 126 on the seal 120 fit into matingrecesses 117 a in the cavity 117 to prevent the seal 120 from moving inthe cavity 117, and thus maintaining the orifice 116 a in directalignment with the orifice 124, as shown more particularly in FIG. 3A.This alignment permits fluid from the inlet handle 110 to flow throughthe seal 120 and into the groove 132 of the outlet handle. The sealorifice 124 is aligned with the orifice 116 a and groove 132, bothduring assembly and during flow. The seal 120 ensures that fluid iscontained within the groove 132, and that fluid input to the device 100via the port 116 can only flow in a path defined by the orifices in eachof the inlet handle 110 and seal 120 and groove 132 of the outlet handle130, to exit the device 100 through the port 134 of the outlet handle130.

The inlet handle 110 and outlet handle 130 are preferably made of amaterial sufficiently robust to withstand the pressures of the intendeduse. In one particular embodiment of the invention, it is intended thatthe device 100 be used in a pressurized infusion system. Consequently,the material selected for inlet handle 110 and outlet handle 130 ispreferably selected to operate under a wide range of pressures from 5-40PSI (i.e., the device being operable for the entire range), making thedevice 100 compatible with pressurized devices. In one particularpreferred embodiment, the material for the inlet and outlet handles 110,130 are selected to be polycarbonate or other materials of similarhardness coefficient. For example, the inlet and outlet handles can bemade of a hard plastic to ensure precise sealing. The seal 120 is madeof a soft plastic to provide a cushioned seal when placed between theinlet and outlet handles 110, 130 and seals the device to prevent fluidleakage. The tolerance of the molds to produce the inlet and outlethandles should take into account that the inlet and outlet handlesshould be of sufficient tightness to avoid fluid leakage.

Fluid viscosity, relative position of device, atmospheric pressure,ambient temperature and other factors affect actual flow rates.Calibration of flow rates and enhanced controllability are importantclinical features. The flow control device of the present invention maybe calibrated and delivered to the user with charts that correlate fluidviscosity with flow rate for various fluids under various conditions aspart of the operating manual. The charts provided may include adjustmentfactors to account for and compensate for, among other factors thataffect actual flow rates, fluid viscosity, relative position of device,atmospheric pressure, and/or ambient temperature and other factors.

Conventional flow regulators are rated in ml/hr (milliliters per hour)and based on gravity flow for a low viscosity “Saline solution”. Thisway of labeling flow regulators is misleading and cannot be correlatedto parametric variations. Instead, the device 100 has a numbering systemthat replaces the otherwise imprecise ml/hr indicators with numberseither from 1-6, 1-10 or 1-100% thus avoiding empirical discrepancieswhen different fluids are utilized. For example, in the presentparticular embodiment shown in FIGS. 1 and 2, the scale 114 on thedevice 100 is labeled 1-6, which in the present example are not anumerical value in ml/hr. Each number on the scale 114 is aligned with ahash mark 114 a, and the scale 114 additionally includes interveninghash marks 114 a disposed halfway between the numbers, which hash marks114 are alignable with an indicator or arrow 136 on the outlet handle130, for easy and understandable selection of the flow. Moreparticularly, the inlet handle 110 and gasket or seal 120, with thealigned orifices, 116 a, 124, rotate relative to the groove 132 of theoutlet handle 130, to align the orifices 116 a, 124 with differentportions of the groove 132, thus controlling the flow between the inletport 116 and the outlet port 134.

Referring now to FIGS. 7-12B, there is shown a variable flow controldevice 200 in accordance with another particular embodiment of thepresent invention. The flow control device 200 is similar in manyrespects to that of FIGS. 1-6B. More particularly, the flow controldevice 200 includes an inlet handle 210 including an inlet port 216,orifice 216 a, scale 214, chamber or cavity 217 and shaft 218, all ofwhich operate similarly to the correspondingly named parts described inconnection with FIGS. 1-6B. The flow control device 200 additionallyincludes a seal 220 and an outlet handle 230. However, instead of asingle orifice, the seal 210 includes a plurality of orifices 222alignable between the orifice 216 a of the inlet handle 210 and achannel 236 containing an outlet orifice 232 connected to the outletport 234 of the outlet handle 230.

However, the scale on the outlet handle 210 is mounted, in the presentembodiment, on a dial 214 that can be rotated relative to the body ofthe inlet handle 210. The chamber 217 containing the seal 220 forms thebase of the dial 214, so that, when received in the chamber 217, theseal 220 is rotated when the dial 214 is rotated. Rotation of the dial214 to a discretely marked position will align one of the orifices 222(or no orifice, in the case of the “OFF” setting) with the inlet orifice216 a and with the channel 236 of the outlet handle 230. The channel 236is sized to receive fluid from any of the holes 222 and channel it tothe outlet orifice 232 at the base of the channel 236.

In one particular embodiment of the invention, the scale on the dial 214is operable between Off and 10 and the seal 220 includes 10 orifices222. Rotation of the dial 214 relative to the arrow or indicator 235 onthe outlet handle 230 places a different orifice 222 between the inletorifice 216 a and the channel 236 containing the outlet orifice 232.Each of the different orifices 222 are differently sized from oneanother to provide a correspondingly different flow through the seal220, and thus out the outlet port 234. In the present example eachorifice 222 is sized to provide a percentage of flow through the seal220. In the example shown, each of the 10 markings on the scale of thedial 214 represents 10% of the flow, such that aligning the number 1 onthe dial 214 with the arrow 235 aligns an orifice 222 that permits fluidto flow at a flow rate of 10% of the total possible flow rate, betweenthe inlet orifice 216 a and the outlet orifice 232. Similarly, selectingthe hash mark next to the number 2 represents 20% of the total possibleflow rate, while selecting the hash mark next to the number 10represents 100% of the total possible flow rate. Although the presentexample uses 10 discrete orifices 222 to provide flow rates changeableat 10% increments, this is not meant to be limiting, as more or fewerorifices 222 can be used. For example, if desired, 100 orifices 222 canbe provided to permit the selection of a flow rate between 0 and 100% in1% increments. Other numbers of orifices 222 can be used withoutdeviating from the spirit of the invention.

Additionally, the flow control device 200 is preferably made of the samematerials, and for operation in the same pressure range, as the device100, described above. Additionally, the device 200 is assembled using asnap-fit coupling between a shaft 218, having a collar 218 a, and a snapfitting 238 on the outlet handle 230, with the seal 220 disposed therebetween.

Alternately, if desired, instead of a plurality of orifices 222 beingprovided on the seal 220, the plurality of orifices can be provided on aface of the outlet handle, as shown more particularly in the embodimentof FIGS. 13 and 14. Referring more particularly to FIGS. 13 and 14, theseal can be the seal 120, as described in connection with the embodimentof FIG. 1. Similarly, the inlet handle can be the inlet handle 110described in connection with the embodiment of FIG. 1. Thus, thecombination of inlet handle 110 and seal 120 would operate as describedin connection with FIG. 1 (i.e., with the single orifice of the seal 120fixedly aligned with the orifice 116 a of the inlet handle 110).However, instead of the outlet handle 130, the device 300 includes theoutlet handle 330, the face of which includes a plurality of orifices332, each of a different size, as described in connection with theorifices 222 of FIG. 7. The outlet handle 330 contains various internal“channels” connecting the orifices 332 to the outlet port 334, throughwhich the fluid travels. Rotation of the inlet handle 110 relative tothe outlet handle 330 provides fluid from the inlet port 116, via theorifices 116 a (see, for example, FIG. 3A) and 124, to an aligned one ofthe orifices 332. The diameter of the aligned one of the orifices 332and/or the channel connecting it to the port 334, define the rate offlow.

As with the other embodiments, the numbers on the scale 114 can bealigned with the arrow or indicator to align the orifices 116 a, 124with a particular desired orifice 332 and provide the fluid to theoutlet port 334 at the rate defined by the particular respective orifice332.

Referring now to FIGS. 15-18, there is shown a flow control device 400in accordance with a further embodiment of the present invention. Thedevice 400 includes an inlet handle 410 having a rotating dial 414, anoutlet handle 430 and a seal 420 including specialized groupings oforifices 422 defined for each possible discrete setting for the dial414. The flow control device 400, i.e., the elements 410, 420 and 430,is preferably made of the same materials, and for operation in the samepressure range, as the corresponding elements of the device 100,described above. Additionally, the device 400 is assembled using asnap-fit coupling between a shaft and snap fitting, with the seal 420disposed therebetween, as was described in connection with the previousembodiments.

Additionally, in the present embodiment, the rotation of the flowregulator dial 414 causes the flow from the inlet orifice or port 416 tobe connected to the outlet handle 430, via a particular group oforifices 422 in the seal 420. More particularly, the seal 420 includesfifteen discrete positions, each of which has a unique group orcombination 422 of orifices representing a specific binary number. Inthe present example, the inlet orifice 416 a may be a single orifice, asshown, which is large enough to feed fluid to all of the orifices 422 ain a particular group 422. Alternately, if desired, the inlet 416 can beconfigured to have four orifices 416 a, one for alignment with each ofthe four possible orifice locations in a group 422 on the seal 420.Additionally, if desired, the orifice 416 a can be in the form of a slotor groove (such as the groove 436 on the outlet handle), to ensure thatfluid from the inlet port 216 will be provided to any open orifice in agroup of orifices 422. The number of orifices open between the inletorifice 416 a, and the outlet slot 436 and orifice 432, as well as theirsizes, define the flow rate for each particular position or setting ofthe dial 414. As can be seen, with the use of four possible orifices 422a per group 422, there are fifteen possible flow rate settings availableto the flow rate device 400, as shown in Table 1, here below.

TABLE 1 ORIFICE POSITION No. ONE TWO THREE FOUR 1 1 0 0 0 2 0 1 0 0 3 11 0 0 4 0 0 1 0 5 1 0 1 0 6 0 1 1 0 7 1 1 1 0 8 0 0 0 1 9 1 0 0 1 10 0 10 1 11 1 1 0 1 12 0 0 1 1 13 1 0 1 1 14 0 1 1 1 15 1 1 1 1

As shown more particularly in FIG. 18, the size of each orifice 422 a ina group 422 is, preferably, different from the size of every otherorifice 422 a in the group 422, which provides the high resolution offifteen unique possible dial positions. Additionally, the size of theholes should gradually increase. For example, in order to effectuate thefifteen unique settings of Table 1, in the present illustrative example,the orifice 2 must be larger than (i.e., have a greater flow through)the orifice 1. Similarly, orifice 3 must be larger than orifices 1 and2, combined, and orifice 4 must be larger than orifices 1, 2 and 3combined. In one particular embodiment of the invention, the secondorifice is double the flow rate of the first orifice, the third orificeis double the flow rate of the second orifice and the fourth orifice isdouble the flow rate of the third orifice, and so on for the totalnumber of orifices used. Note that that use of four orifices per groupis not meant to be limiting, as more or fewer orifices 422 a per group422 may be used without departing from the scope of the invention. Forexample, in another particular embodiment of the invention (not shown),each group of orifices could have between 1 and 3 orifices, thusdefining 8 unique flow rate settings, as defined by Table 2, herebelow.

TABLE 2 ORIFICE POSITION No. ONE TWO THREE 1 1 0 0 2 0 1 0 3 1 1 0 4 0 01 5 1 0 1 6 0 1 1 7 0 1 1 8 1 1 1

Additionally, if desired, in addition to, or instead of, the seal havinggroups of orifices, as described, the outlet handle, itself, may includea sequence of orifices, defined by Table 1, that permit fluid to flowthrough from seal into one such group of orifices. The relative positionof the inlet handle and seal orifices with a particular group oforifices in the outlet handle determines the flow rate. One particularexample of a flow rate device 500, wherein the orifice groups 532 are onthe outlet handle, instead of on the seal, is shown in FIG. 24. Moreparticularly, the inlet handle orifice is aligned with a slot 522 on theseal 520, which can be aligned with each linear orifice group of 532 onthe outlet handle 530 by rotating the inlet handle 510 relative to theoutlet handle to align with a setting marked on the dial 514. Thischanges the position of the slot 522 (and inlet orifice 516) relative tothe surface of the outlet handle 530, and aligns the slot 522 with oneof the particular orifice groups 532. Channels in the outlet handle 530direct the fluid from each orifice 532 a of a group 532 to the outletport (Not shown) of the device 500.

Referring now to FIGS. 19-20, there is shown a pump 1 and a syringe 2inserted in the pump 1. A flow regulator 3 according to the invention isconnected to the syringe 2. The flow control device 3 can be any of thedevices 100, 200, 300, 400 discussed hereinabove. The pump 1 is designedwith a pressure rating that is higher than elastomeric devices. Thesyringe 2 is a conventional, commercially available syringe. The flowregulator is provided with the necessary tubing and with commerciallyavailable universal female and male luer lock connectors. The femaleluer lock 4 is connected to the source of infusion and the male luerlock 8 is connected to the patient via a catheter or an additionalextension infusion set.

FIG. 22 shows the infusion pump 1 of FIG. 19 on a larger scale. Theillustrated infusion pump 1 is the preferred embodiment in the context,but it will be understood that the flow regulator 3 according to theinvention may also be used with other infusion pumps. The novel pump haslabel surface 10 for branding and the like. A rotating knob 11 or handle11 may be used to initialize the pump. A viewing window 12 is providedfor ascertaining that the syringe is properly inserted in the pump 1.

The following sequence may be performed by the user/patient in order toinitialize the system and start the delivery of the infusion medicament:

-   -   First, the regulator 3 must be set to zero in order to block any        flow there through. Then the luer lock connector is attached to        the filled syringe 2.    -   Next, the needle set is connected to the luer lock on the        regulator 3.    -   Then the pump drive is opened by rotating the handle 11        counterclockwise until it stops.    -   Then the syringe 2 is loaded and locked into the pump 2 by        inserting the syringe plunger into the pump 1 and rotating the        syringe 90° until it “clicks” in place.    -   Next, the user can verify that the syringe flange shows in the        viewing window 12, so as to confirm that the syringe is properly        loaded.    -   Now, the pump is ready for activation. It is activated by        rotating the handle 11 clockwise.    -   The system is primed by turning the regulator dial to position        5, for instance, and, when the first drop of fluid comes out of        the needle set, turning it back to the zero position.    -   Now the infusion can be started as prescribed by the health        provider. The user should thereby refer to the flow control        guide.    -   The delivery may be stopped by turning the regulator dial to the        zero or off position.    -   The syringe may be removed after the regulator has been set to        zero and the handle 11 is rotated counterclockwise until the        stop is reached.

FIG. 23 is an enlarged view of a luer lock 4 for use in the novelinfusion system. The luer lock is particularly easy to handle due to itsergonomic geometry.

The entire flow control device 3 and connection system is illustrated inFIG. 19. The female luer lock 4 is provided for conventional connectionto the delivery end of the syringe 2. A removable cap 13 is provided soas to protect the luer lock 4 during shipping and storage. A tubingsection 6 leads from the luer lock 4 to the inlet side of the flowregulator 3. The outlet side of the flow regulator 3 is connected viatubing 7 to a further connector 8 (here, a male luer lock), which isconnected into the delivery IV tubing system 9.

The flow control device or regulator of the present invention isdifferent from all other flow regulators in the market, in part, becauseall others are unable to withstand the considerable pressures suppliedby the pump 1, or other pumps with similar pressure ratings.Additionally, the flow control device of the present invention providesgreater resolution for more accurately controlling the rate of fluidflow.

As can be seen from the foregoing, flow control device 3 allows for theinfusion pump to infuse a rate that is controllable by the user.Additional flow regulation control can be accomplished by incorporatingone or more supplemental adjustable dial layers. For example, referringnow to FIG. 21, there is shown another embodiment of a flow rate controldevice 20, wherein two dials 22, 24 are used to improve precision incontrolling flow rate. The first layer (22, 30) provides a coarsecontrol with methods described in connection with the foregoingembodiments discussed above. The second layer (24, 32) provides a finecontrol, again with methods described in the foregoing embodimentsdiscussed above. This is not meant to be limiting, as additional layersmay be provided without departing from the scope of the invention.

More particularly, as shown in FIG. 21, the two layers are designed toprovide a combination of coarse and fine control levels, thus greatlyenhancing the actual flow rate controllability based on theselections/adjustments made on the first dial 22 and second dial 24.Each of the dials 22, 24 may work in accordance with the principlesdescribed herein. The second dial 24 may provide fine flow control,further refining the output controlled by the first dial 22, whichprovides coarse flow control. In one particular embodiment, the seconddial has a base diameter ranging between 0-10% of the first dial, whichhas a diameter ranging between 0-100% (coarse flow control). Thecombination of the first and the second dials 22, 24 yieldssignificantly enhanced control. Additional layers having a compoundingeffect on enhanced resolution, controllability and accuracy of thedevice 20 may be provided. Each layer may use the same or a differentflow control mechanism as any other layer, as desired. For example, thecoarse layer, including the dial 22 and outlet handle portion 30, canmake use of a variable diameter groove for controlling flow, such asdescribed in connection with the device 100 FIG. 1, while the secondlayer, including the dial 24 and the outlet handle portion 32 may makeuse of one of the other flow control mechanisms described in connectionwith the devices 200, 300, 400, 500. This is not meant to be limiting,as any combination of layers and any number of layers utilizing thevariable flow control mechanisms described in connection with thedevices 100, 200, 300, 400, 500 may be used in any of the layers withoutdeparting from the spirit of the present invention.

As can be seen from the foregoing, the present invention implementsfeatures that improve flow control as well as safety resulting from suchimproved flow rate control when compared to the performance of devicesin the prior art. The invention solves important limitations inherent tonon-electric infusion systems. Non electric infusions systems aregenerally controlled by certain small diameter tubing (rate set) thatregulates the flow. This method presents limitations including inabilityto change flow rate without changing the rate set, incorrect flow ratelabeling due to the varying viscosities of fluids administered, andundesired flow rates due to device design limitations, patientconditions and environmental factors.

The flow rate control devices described hereinabove can be used inconnection with gravity infusion devices and/or pressurized infusiondevices, including constant or semi-constant force infusion devices.Additionally, if desired, a pressure sensor may be provided the outputof which can be used to by self-adjusting mechanism or circuit toautomatically adjust the flow rate of the flow rate device to reduceflow changes relative to pressure variations, patient conditions andother therapy factors.

The present disclosure is provided to allow practice of the invention,after the expiration of any patent granted hereon, by those skilled inthe art without undue experimentation, and includes the best modepresently contemplated and the presently preferred embodiment. Nothingin this disclosure is to be taken to limit the scope of the invention,which is susceptible to numerous alterations, equivalents andsubstitutions without departing from the scope and spirit of theinvention.

What is claimed is:
 1. A flow rate device configured for connection in aflow path between a non-electric infusion pump and a patient, the flowrate control device comprising: an inlet handle; an outlet handle,wherein said inlet handle is rotatable relative to said outlet handle; afluid path disposed between said inlet handle and said outlet handle,said fluid path having at least one manually adjustable dimension;wherein the at least one manually adjustable dimension includes a widthof the fluid path; and said inlet handle and said outlet handle composedof materials that can withstand pressures of from 5 PSI-40 PSI; whereinsaid flow rate control device further comprises: an inlet port in saidinlet handle; a groove in said outlet handle, wherein said grooveincludes a diameter that varies along a length of the groove; an outletport in said outlet handle fluidly coupled to said groove; a sealbetween said inlet handle and said outlet handle, said seal beingfixedly coupled to said inlet handle, wherein said inlet handle and saidseal are rotatable relative to said outlet handle, wherein said sealincludes at least one orifice for fluid flow therethrough, wherein saidat least one orifice is selectively alignable with said groove along thelength of the groove, whereby a fluid is capable of flowing in sequencethrough said inlet port, said at least one orifice, said groove, andthen through said outlet port.
 2. A flow rate device configured forconnection in a flow path between a non-electric infusion pump and apatient, the flow rate control device comprising: an inlet handle; anoutlet handle, wherein said inlet handle is rotatable relative to saidoutlet handle; a fluid path disposed between said inlet handle and saidoutlet handle, said fluid path having at least one manually adjustabledimension; wherein the at least one manually adjustable dimensionincludes a width of the fluid path; and said inlet handle and saidoutlet handle composed of materials that can withstand pressures of from5 PSI-40 PSI; wherein said flow rate control device further comprises:an inlet port in said inlet handle; a channel in said outlet handle; anoutlet port in said outlet handle fluidly coupled to said channel; aseal between said inlet handle and said outlet handle, said seal beingrotatable relative to said inlet handle and to said outlet handle,wherein said seal includes a plurality of groups of orifices for fluidflow therethrough, wherein each of said plurality of groups of orificesis selectively alignable with said inlet port and said channel, wherebya fluid is capable of flowing in sequence through said inlet port, oneof said plurality of groups of orifices, said channel, and then throughsaid outlet port.
 3. The flow rate control device of claim 2, whereinsaid inlet port comprises a groove.
 4. The flow rate control device ofclaim 2, wherein each orifice in each group of orifices has a size, andeach size of each orifice is different from the size of every otherorifice in each group of orifices.